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Sacituzumab Govitecan and Zimberelimab w/SRS in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

Sacituzumab Govitecan and Zimberelimab w/SRS in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases

Phase I/II Study of Stereotactic Radiation and Sacituzumab Govitecan With Zimberelimab in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases (TARGET-TNBC)

NCT06238921•H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

Summary

This is a Phase I/II Study to determine the safety and efficacy of Sacituzumab Govitecan and Zimberelimab with stereotactic radiation (SRS) in participants with metastatic triple negative breast cancer with brain metastases, compared to treatment with Sacituzumab Govitecan alone.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Provision of signed and dated Informed Consent Form (ICF).
•Stated willingness to comply with all study procedures and availability for the duration of the study.
•Age ≥ 18.
•Triple negative breast cancer; to fulfill the requirement of triple negative disease, a breast cancer must express (≤ 10%), by immunohistochemistry (IHC), of the hormone receptors (estrogen receptor \[ER\] and progesterone receptor \[PR\]).
•Breast cancer as documented by extracranial tumor biopsy with brain metastases documented from MRI brain imaging or intracranial surgical pathology.
•Eligible for Stereotactic radiosurgery (SRS) to brain metastases or to the post-operative bed.
•Measurable brain disease per RANO-BM criteria1 that can be measured in at least one dimension as ≥ 0.5 cm for both intact brain metastases and post-operative cavities.
•Maximum diameter of the largest intact brain metastases ≤ 4 cm.
•Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
•Symptomatic patients having undergone surgery or on stable doses of steroids ≤ 8 mg/day dexamethasone will be enrolled.
+4 more criteria

Exclusion Criteria

•Presence of leptomeningeal disease.
•Women who are pregnant or breastfeeding.
•Known history of HIV-1 or 2 with detectable viral load.
•Active, known, or suspected autoimmune disease. Patients with an autoimmune paraneoplastic syndrome requiring concurrent immunosuppressive treatment are excluded. Exceptions are patients with type I diabetes mellitus, hypothyroidism only requiring thyroid replacement therapy, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
•History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
•Met any of the following criteria for cardiac disease:
•1. Myocardial infarction or unstable angina pectoris within 6 months of enrollment
•2. History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation
•3. New York Heart Association (NYHA) Class III or greater congestive heart failure or left ventricular ejection fraction of \< 40%
•Any patient requiring supplemental oxygen therapy.
+12 more criteria

Locations (1)

Moffitt Cancer Center

Tampa, Florida, United States

Key Dates

Start Date

December 19, 2024

Primary Completion Date

February 1, 2027

Completion Date

February 1, 2027

Last Updated

December 5, 2025

Enrollment

ESTIMATED participants

Conditions

Breast CancerTriple Negative Breast Cancer

Interventions

Stereotactic Radiation

RADIATION

Zimberelimab

DRUG

Sacituzumab govitecan

DRUG

Contacts

Michelle DeJesus

CONTACT

813-745-6911 Michelle.DeJesus@moffitt.org

Kamran Ahmed, MD

CONTACT

kamran.ahmed@moffitt.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Sacituzumab Govitecan and Zimberelimab w/SRS in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases

Inclusion Criteria

Exclusion Criteria

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